Health Complaints Attributed to Previous Amalgam FillingsIMCRNCT02081664
Feasibility of an Integrated Medical Care Program for Patients With Continuing Health Complaints After Amalgam Removal
A study testing lifestyle intervention in people with Health Complaints Attributed to Previous Amalgam Fillings, run by University of Tromso at 1 site in Norway.
Trial summary
Some patients report relief of symptoms after amalgam removal. However, a large group of patients are still suffering from partly severe health complaints even after the removal of amalgam. To date, no biological/medical explanation for these Amalgam attributed health complaints is available. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Health Complaints Attributed to Previous Amalgam Fillings
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The research population should be permanent residents in Norway and be between 20 to 70 years of age and able to comply with the protocol
- Participants must have removed all dental amalgam fillings (screening by study dentist)
- Still having health complaints which have not disappeared after removal of the dental amalgam fillings
- Minimum duration of health complaints of 12 months since removal of the last amalgam filling
- There is not yet any biological/medical explanation for their health complaints
- Willing and motivated to take part in the IMCR program as it is described
Who cannot join
- Patients with ongoing cancers, severe cardiopulmonal, neurological, or psychiatric diseases or mental retardation (screening by study GP)
- Life threatening disease
- Dental conditions requiring treatment before entering the program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial
Some patients report relief of symptoms after amalgam removal. However, a large group of patients are still suffering from partly severe health complaints even after the removal of amalgam. To date, no biological/medical explanation for these Amalgam attributed health complaints is available.
The objective of this study is to develop an integrated medical care rehabilitation program and determine if it is a valid and feasible treatment for patients with persistent symptoms after amalgam removal. Such a comprehensive concept has to date not been operationalized in Norway, but information about the feasibility and the challenges around such a rehabilitation program are required, in order to prepare for a possible controlled and randomized study evaluating the effects of the suggested integrative care treatment program. This treatment program will focus on "learning by practicing", hence the study participants will be enrolled into a group program focusing on life-style changes. In addition to the life-style oriented group program, an individualized treatment strategy with therapies out of the spectrum of Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part of the program is based on the results of a survey, related to use of CAM therapies, conducted in 2012 among the members of the patient organization "Forbundet Tenner og Helse".
Participants of this treatment program must amongst other inclusion criteria have removed all dental amalgam fillings and experience symptoms which have not disappeared after removal of the dental fillings. Specific exclusion criteria are stated. The group program consists of 12 sessions which are held once per week for a whole day. Added to this is a choice of CAM therapies from a hierarchic list, established from the survey, and which accordingly is based on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of treatment), and three month later. The aim of this study is to test the feasibility of an integrated medical care rehabilitation program for patients in Norway who have had their Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a lifestyle oriented group program with individualized CAM therapies in form of an outpatient program.
- Being tested
- lifestyle intervention
- Keywords
- Amalgam attributed health complaints, feasibility pilot study, integrated medical care program, lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Other | life-style oriented group program together with an individualized treatment program using therapies out of the spectrum of Complementary and Alternative Medicine (CAM) Receives: Behavioral: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
achieved patient enrollment rates (number of patients eligible)
number of patients who are willing to participate and are eligible
Measured: 8 weeks
Secondary outcomes (1)
MYMOP (scale from 0 to 6)
MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.
Measured: difference between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Complaints Attributed to Previous Amalgam FillingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frauke Musial, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081664
- Sponsor's protocol ID
- 2014/34974(NSD)
- Other IDs
- 2014
- Acronym
- IMCR
- Status last verified
- Jun 2015
- First submitted
- 5 Mar 2014
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial
- ClinicalTrials.gov ID
- NCT02081664
- Acronym / sponsor ID
- IMCR / 2014/34974(NSD)
- Keywords
- Amalgam attributed health complaints, feasibility pilot study, integrated medical care program, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some patients report relief of symptoms after amalgam removal. However, a large group of patients are still suffering from partly severe health complaints even after the removal of amalgam. To date, no biological/medical explanation for these Amalgam attributed health complaints is available.
The objective of this study is to develop an integrated medical care rehabilitation program and determine if it is a valid and feasible treatment for patients with persistent symptoms after amalgam removal. Such a comprehensive concept has to date not been operationalized in Norway, but information about the feasibility and the challenges around such a rehabilitation program are required, in order to prepare for a possible controlled and randomized study evaluating the effects of the suggested integrative care treatment program. This treatment program will focus on "learning by practicing", hence the study participants will be enrolled into a group program focusing on life-style changes. In addition to the life-style oriented group program, an individualized treatment strategy with therapies out of the spectrum of Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part of the program is based on the results of a survey, related to use of CAM therapies, conducted in 2012 among the members of the patient organization "Forbundet Tenner og Helse".
Participants of this treatment program must amongst other inclusion criteria have removed all dental amalgam fillings and experience symptoms which have not disappeared after removal of the dental fillings. Specific exclusion criteria are stated. The group program consists of 12 sessions which are held once per week for a whole day. Added to this is a choice of CAM therapies from a hierarchic list, established from the survey, and which accordingly is based on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of treatment), and three month later. The aim of this study is to test the feasibility of an integrated medical care rehabilitation program for patients in Norway who have had their Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a lifestyle oriented group program with individualized CAM therapies in form of an outpatient program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Other | Behavioral: lifestyle interventionlife-style oriented group program together with an individualized treatment program using therapies out of the spectrum of Complementary and Alternative Medicine (CAM) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The research population should be permanent residents in Norway and be between 20 to 70 years of age and able to comply with the protocol
- Participants must have removed all dental amalgam fillings (screening by study dentist)
- Still having health complaints which have not disappeared after removal of the dental amalgam fillings
- Minimum duration of health complaints of 12 months since removal of the last amalgam filling
- There is not yet any biological/medical explanation for their health complaints
Key exclusion criteria (3 listed)
- Patients with ongoing cancers, severe cardiopulmonal, neurological, or psychiatric diseases or mental retardation (screening by study GP)
- Life threatening disease
- Dental conditions requiring treatment before entering the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle intervention | Behavioural | Lifestyle intervention |
Primary outcome
achieved patient enrollment rates (number of patients eligible)
Time frame: 8 weeks
number of patients who are willing to participate and are eligible
1 secondary outcome
MYMOP (scale from 0 to 6)
Time frame: difference between baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frauke Musial, PhD principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Health Complaints Attributed to Previous Amalgam Fillings, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
achieved patient enrollment rates (number of patients eligible) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.